Clinical trials

Developing the future of medicine

Advances in medicine come from new ideas developed through clinical research.

At UCHealth, we conduct hundreds of clinical trials (also called research trials or research studies) in our ongoing effort to discover and deliver more effective treatments. Our goal is to translate discoveries made in the laboratory to patients as quickly as possible, while strictly adhering to our conflict of commitment and conflict of interest policy.

Clinical trials are conducted to study new medications, devices, diagnostic products and treatment regimens intended for human use. Clinical trials are done to determine whether new drugs or treatments are safe and effective. Several stages of clinical trials are completed before a drug or device may be approved for general medical use, if ever.

Drug and device testing begins with extensive laboratory research which can involve years of experiments. If the initial laboratory research is successful, researchers send the data to the Food and Drug Administration (FDA) for approval to continue research and testing in humans. Once approved, human testing of experimental drugs and devices can begin.

Before participating in a study, talk to your health care provider to learn about the risks and potential benefits.

Phases of clinical trials

Clinical trials are conducted in a series of steps called “phases.” Each phase has a different purpose and helps researchers answer different questions.

Phase I trials: Researchers test a drug or treatment in a small group of people (20–80) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.

Phase II trials: The new drug or treatment is given to a larger group of people (100–300) to determine its effectiveness and to further study its safety.

Phase III trials: The new drug or treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely.

Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment’s benefits, and optimal use.